BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II BRONCHOVIDEOSCOPE

    MDR report key: 4240324 · Received October 30, 2014

    Report

    Report Number
    2951238-2014-00489
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    January 1, 2014
    Report Date
    October 10, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP
    Product Code
    EOQ
    PMA / PMN Number
    K023984
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE PT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADD'L INFO BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE INSERTION TUBE PART OF THE BRONCHOSCOPE APPROXIMATELY ONE INCH PROXIMAL TO THE BENDING SECTION FLIPPED BACKWARDS. THE PHYSICIAN WAS UNABLE TO STRAIGHTEN OUT THE END. IT WAS REPORTED THAT AN ANESTHESIST WAS CALLED INTO THE PROCEDURE ROOM TO ASSIST WITH THE USE OF LARYNGOSCOPE, BUT THIS WAS UNSUCCESSFUL. THE PT RECEIVED MINOR TRAUMA TO THE RIGHT NOSTRIL AS THE DEVICE WAS BEING WITHDRAWN. THE INTENDED PROCEDURE WAS NOT COMPLETED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THE REPORTED EVENT, BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695141 EVIS EXERA II BRONCHOVIDEOSCOPE BRONCHOSCOPE EOQ OLYMPUS MEDICAL SYSTEM CORP BF-Q180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1